MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS ACCESS SOLUTION; INTRODUCER, CATHETER

Device Problem Use of Device Problem (1670)

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 02/22/2023

Event Type  Injury  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that the patient experienced a cardiac perforation and subsequent pericardial effusion and cardiac tamponade.During a left atrial appendage (laa) closure procedure, during the transseptal crossing, the physician pierced the back wall of the left atrium (la) with the dilator of the versacross sheath.There were no product issues, the physician stated it was operator error.A pericardial effusion with a cardiac tamponade occurred as a result.The procedure was aborted, and the surgeon was called.A window and chest tube were inserted, and the patient was admitted to cardiovascular intensive care unit (cvicu).The patient was stable when they left the operating room (or).

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that the patient experienced a cardiac perforation and subsequent pericardial effusion and cardiac tamponade.During a left atrial appendage (laa) closure procedure, during the transseptal crossing, the physician pierced the back wall of the left atrium (la) with the dilator of the versacross sheath.There were no product issues, the physician stated it was operator error.A pericardial effusion with a cardiac tamponade occurred as a result.The procedure was aborted, and the surgeon was called.A window and chest tube were inserted, and the patient was admitted to cardiovascular intensive care unit (cvicu).The patient was stable when they left the operating room (or).

• Brand Name: VERSACROSS ACCESS SOLUTION
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BAYLIS MEDICAL COMPANY INC.; 5825 explorer drive; mississauga, on ; CA
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17606425
• MDR Text Key: 321773784
• Report Number: 2124215-2023-42547
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/23/2023
• Supplement Dates Manufacturer Received: 07/31/2023
• Supplement Dates FDA Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 71 YR